The Indian government recently required all pharmaceutical companies in the country to apply new Good Manufacturing Practises (GMP) in order to align their procedures with global standards.
Central Idea
The new standards are intended to address major issues such as suspected contamination instances in India-made items, flaws in quality control methods, and a lack of conformity to worldwide requirements. India hopes to improve the quality of pharmaceuticals offered in both domestic and global markets by guaranteeing adherence to the amended GMP.
Concerning Good Manufacturing Practises (GMP)
- GMP is a set of guidelines and quality management concepts that assure pharmaceutical items, as well as other products in the food and healthcare industries, are produced and regulated in a consistent manner to satisfy quality standards acceptable for their intended use.
- GMP encompasses all parts of the manufacturing process, such as the premises, equipment, staff, materials, production, quality control, documentation, and completed product storage.
The Need for Improved Standards
- Alignment with Global Standards: Implementing the new GMP requirements will align the Indian pharmaceutical industry with global standards, ensuring that the country’s products match international regulators and consumers’ expectations.
- Incidences of Contamination: Numerous incidences of contamination in India-made syrups, eye drops, and eye ointments have been documented in different countries, with terrible results. These accidents have highlighted the importance of tighter quality control methods.
- Deficiencies discovered: A risk-based assessment of manufacturing units showed various flaws, including a lack of testing incoming raw materials, insufficient product quality review, a lack of quality failure investigation, infrastructure concerns, and a lack of competent people.
Importance of Revised GMP
- Standardised procedures: The revised standards will ensure that pharmaceutical businesses follow standardised procedures and quality control systems, hence improving the quality of medications manufactured and sold in India and around the world.
- Chitan Shivir’s recommendations: Following the contamination occurrences, one of the advised measures at a Chitan Shivir was the implementation of the amended GMP. The stakeholders also advocated for the establishment of a national IT platform to enhance consistency in licencing and inspection processes across states.
The Advantages of Revised GMP Implementation
- Increasing Regulatory Trust: Uniform quality standards across the business will establish trust in foreign regulators, potentially decreasing the need for repeat inspections.
- Improving Domestic Market Quality: The adoption of updated GMP would improve the quality of pharmaceuticals sold in India, benefiting both consumers and public health.
Significant Changes in the Revised GMP Guidelines
- The new requirements include a pharmaceutical quality system to assure consistent product quality and a thorough assessment of deviations or failures.
- Quality Risk Management: Companies will be obliged to undertake risk assessments and execute preventive measures in order to effectively manage quality hazards.
- Product Quality Review: All items will be subjected to regular quality checks to ensure consistency of quality and processes.
- Equipment Validation: Pharmaceutical organisations will need to validate equipment in order to assure the accuracy and dependability of production operations.
- GMP-related Computerised Systems: To avoid data manipulation and unauthorised access, the recommendations emphasise the use of computerised systems for GMP-related operations.
- Other Product Requirements: The new schedule M specifies the standards for biological goods, radioactive agents, plant-derived products, and investigational products for clinical trials.
Source: https://indianexpress.com/article/explained/explained-health/revised-manufacturing-rules-for-drug-firms-what-changes-and-why-8879305/